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The 13th italian national meeting of pharmaceutical qualified persons (QP)

The 13th italian national meeting of pharmaceutical qualified persons (QP) was held last 28 November.

The speeches of the AIFA officers Dr. Fulfaro and Dr. Delbò were particularly significant.

Dr. Fulfaro highlighted the following aspects:

  • Riorganisation of the GMPMED Unit: it is final that inspectors, after the last inspection, always take care of the inspection follow-up until the issue of a new MIA;
  • Reduction of the time required to close the follow-up;
  • Reduction of the time required to issue the MIA;
  • Reduction of the time required to process administrative documents (15 days)
  • Increase in the number of inspections;
  • Essential and non essential changes – assigned directly to technical assessor who will carry out the administrative check; extreme care is therefore required in the administrative documentation and payments;
  • The most integrative documentation requested:
    • Media Fill report, qualification/validation report are missing,
    • the qualification/validation strategy is little detailed,
    • the activities the company wants to carry out is little detailed;
  • The deviations detected during the inspections are mostly related to:
  1. impurities
  2. smoke test
  3. suitable assessment of the use of isopropyl alcohol;
  4. lack of investigations and controls on moulds and microbial charge:

Dr. Delbò focused her speech on:

  • article 50 “Authorisation to medicine manufacturing”
  • article 52 “Manufacturing and importation of active substances”
  • Authorisation vs registration
  • Frequency of the inspections established on a risk assessment basis
  • Differentiation between the third countries with which a Mutual recognition agreement is in place and countries acknowledged as “equivalent”. The need of the Written Confirmation (MR countries) and/or quality controls on the incoming materials should be established on a case-by-case basis. This information should be found in the specific agreements between countries.
  • QP – It was specified again and with no chance of contesting that the QP must have a continuative contract as employee of the MIA holder and that no other type of contract is possible, even for specific cases such as API importation.

A very interesting issue discussed during this day was the GROWING TREND of ADVANCED THERAPIES and BIOTECH in Italy and Europe. On this regard the EU Regulation is very important: this was designed to ensure free circulation of the advanced therapy products in Europe, to facilitate access to the EU market and to promote competition of the European companies in this sector, ensuring the maximum level of health protection for patients.

It was specified that 1,000 companies are currently involved in this sector all over the world and that in 2019 only 3 sites were activated in Italy. It is not a niche anymore, but a fast-expanding market.

In this field, regulatory affairs are to be interpreted on a case-by-case basis. The speech on nitrosamines was not very clarifying. The information already reported in the several EMA communication was repeated.

Dr. Di Giorgio confirmed that for the moment Italy will stand by and will not take part into the European tracking system as the EU system is very premature, whereas the Italian system has already faced and solved many problems of the current EU system.

Written By: Barbara Altieri – Valeria Cardinale